Aims and hypotheses
This study aims to determine whether the receipt of a text message sent regularly over a six-month period can reduce suicidal and self-harming behaviour among SAs.
We hypothesize that the routine reception of a text message during a six-month period will:
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1.
Decrease the proportion of reattempters at 6 and 13 months;
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2.
Decrease the number of total reattempts at 6 and 13 months;
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3.
Decrease suicide deaths;
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4.
Decrease suicidal ideations;
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5.
Decrease intervention costs;
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6.
Improve satisfaction through care services.
Study design
The study is a 2-year multicentric randomized controlled trial conducted by the Brest University Hospital, France. Participants are adults discharged after self-harm, recruited in Brest, Lille, Rennes, Nantes, Tours, Vannes, and Saint-Nazaire. Participants will be recruited over a 12-month period. The study is a randomized controlled trial registered on Clinical Trials Registry (ClinicalTrials.gov; number: NCT02106949). It was authorized by ANSM (French Health Ministry) and approved by the Northwest IV Ethical Committee for the Protection of Patients.
Setting
Participating centers are Brest, Rennes, Nantes, Lille, Angers, Tours, Vannes, (France) - public funded specialist mental health services for adults in the Western and Northwestern regions of France.
Participants
Inclusion criteria are: male or female, aged 18 or older, surviving a suicide attempt, discharged from ED or Psychiatric Units (PU), hospitalized for less than 7 days, giving consent, and able to be contacted by phone.
The exclusion criteria are: refusing to participate, underage, incarcerated, under guardianship, without a mobile phone, enrolled in other trials, and in emergency situations where their state of health did not allow obtaining written consent.
In the case of discharge, a follow-up visit or planned hospitalization will be scheduled.
Procedure
Participation in the study will be proposed to all suicidal adults referred to our psychiatric ED meeting the above criteria. In each center, adults who attempt suicide are admitted to the general ED and are evaluated by our ED psychiatrist who decides patients' discharge or hospitalization. Patients will be enrolled after this evaluation. After enrolment, patients will be assigned to the intervention or control group, using an electronic randomization program. At month 6 and month 13, patients in both intervention and control groups will be contacted by phone for the evaluation. A trained psychiatrist will administer the evaluation.
Intervention
Text messages are customized with each patient's name and sent with an identical outreach schedule for each patient. We will send nine different text messages to each patient 48 hours after discharge, at day 8, day 15 and month 1, 2, 3, 4, 5, 6. All the text messages will be sent at 1 pm. The four messages will refer to: the validation of the suffering, recall of the discharge agreement, and the monitoring system, i.e. our outreach continuing care intervention.
They also will include information in regard to the monitoring doctor's name (psychiatrist or general physician), and the date of the scheduled appointment if applicable. The contact phone number will be indicated in each text message transmission and the message will appear as sent from the psychiatric emergencies hotline number reachable 24/7. One example of the messages received by the patients will be: "Mr X, we hope that your situation is getting better and that you could go to the Dr Y consultation (April 7th 2011 at 10 h00). You can call us for anything you may need at 0298000000". A final reminder text message will be sent 48 hours before the call-back telephone evaluation of month 6 and 13. Patients will be followed up by the psychiatrist of their choice or by their general physician. Text messaging monitoring will be proposed as an additional support to their standard of care.
Control intervention
Those in the control group will receive the follow up as usual including psychiatrist or physician consultation.
Outcomes measures
As primary endpoints, we will assess the number of patients who will reattempt suicide in each group at month 6.
As secondary endpoints, we will assess the number of patients who will reattempt suicide at month 13, the number of suicide attempts in the intervention and control groups at month 6 and 13, and the number of deaths by suicide in the intervention and control groups at 6 and 13 month. In both group, suicidal ideations will be assessed at the baseline, 6 and 13-months. Medical costs and satisfaction will be assessed at month 13.
Baseline evaluation will be done in ED or PU before discharge. Socio-demographic details, including age, gender, employment, educational status, history of suicide attempt, country of birth, medical history and details of any treatment being received, will be recorded on a specifically designed, standardized questionnaire.
The Columbia Scale measures suicidal ideation and intent. It is a 25 item screening scale with items including binary variables (yes or no) and variables scales for each question. [12]. It is also available in French.
Axis-I psychiatric diagnoses will be assessed using the International Neuropsychiatric Interview (M.I.N.I.). It is a short, structured diagnostic interview developed for DSM-IV and ICD-10 psychiatric disorders [13]. With an administration time of approximately 15 minutes, it is the structured psychiatric interview of choice for psychiatric evaluation and outcome tracking in clinical psychopharmacology trials and epidemiological studies. It has been validated in French [14].
The medico-economic questionnaire (MEDEC) is a use of care services inventory including binary variables. It is carried out by the method validated by Beecham & Knapp at 13 month [15].
The satisfaction questionnaire was designed by our team [10] to assess whether such outreach system was accepted by the patients. The subjective system effectiveness will be explored to assess patients' acceptability.
Sample size calculation: effect size and statistical power
Expected reattempt rate is about 18% [6,16]. We hope to reduce this rate to 9% in the intervention group. Such a reduction in reattempts with a statistical power of 0.8, requires a sample size of 247 patients in each group. Taking into account the expected proportion of SAs that will not respond to the follow-up message, 530 patients in total will be recruited.
Randomisation/intervention
Random allocation to the intervention group and the control group will be carried out by an independent statistician and will be stratified by center study using blocked randomization and computer generated random numbers. This will be conducted using an online randomization system. This will be concealed from the research team (psychiatrist, nurse). The statistician will notify the study coordinator regarding the group allocation. Text messages will be sent by SIAM program, designed for the pilot study. Once the patient data is entered, the program will generate four independent text messages containing patient's name, doctor's name and monitoring schedule from the date of inclusion. At any time the patient data, date of sending the text message and message content could be modified. At any time, sending messages (transmissions) could be interrupted. The number displayed on the recipient's mobile phone was the psychiatric ED.
Statistical methods
Continuous variables will be summarized using mean, standard deviation, median and inter-quartile range (IQR). Categorical variables will be summarized using frequency, percentage and 95% CI. Means will be compared between the intervention and control groups using the Student test (t-test) or Mann-Whitney test. Comparisons of proportions between groups will be performed using the Chi square test or Fisher's exact test as appropriate.
Generalized linear model will be used to compare the intervention and control groups for each outcome measure over time (baseline, 6 months, 13 months). The corresponding baseline values of each outcome measure will be used as a covariate. In addition, the effects of other possible predictors (such as gender and age) on outcome will be explored.
Analysis of predictive factors of suicide attempt repetition will be performed using logistic regressions. An approach by a decisional tree (CHAID) will also be considered. Analysis of time delay of SA repetition will be performed using conventional methods of survival analysis: Kaplan-Meyer method, log-rank test and Cox model for multifactorial models. The research for specific profiles will be conducted using classification methods to identify clusters with atypical profiles.
An interim analysis will be conducted on the first 250 participants using the O'Brian and Fleming method. If the difference between intervention and control groups is not significant (p <0.5%), statistical significance will have to reach a level of p < 4.8% by the end of the study to demonstrate a significant difference. A Data and Safety Monitoring Board (DSMB) will conduct this assessment.
Safety and supervision
Patients are informed that they can contact the center where they have been treated at any time. Phone contact will be established by a trained psychiatrist and research assistant at month 6 and 13 to assess the outcome measures. If there is no cause for concern after the 6 month phone call evaluation, patients from each group will be informed that they will be contacted at month 13 for a new evaluation. If there are concerns about the participant, contact will be made by phone or face-to-face as to discuss the concerns. If the research fellow is concerned about the participant, an immediate referral will be made to an appropriate service. Any patient considered to be at high risk will be referred to an appropriate service.
